The U.S. Food and Drug Administration has placed a partial hold on clinical trials of the experimental drug selinexor (KPT-330), a XPO1 antagonist.
The trials have been halted by the FDA due to incomplete information in the Investigator’s Brochure (IB), which includes an incomplete list of Serious Adverse Events (SAEs) associated with selinexor. This partial clinical hold placed by the FDA prevents new patients to be enrolled into clinical trials with selinexor. However, patients with stable disease or better may remain on selinexor therapy. So far, nearly 2,000 patients have been treated with selinexor.
Consequently, at the FDA’s request, Karyopharm, the drug’s manufacturers, have amended the IB and the informed consent documents accordingly. The updated documents were submitted to the FDA on 10th March 2017.
Currently, selinexor is being evaluated in multiple studies in R/R patients with B-cell lymphoma, in particular aggressive DLBCL and CLL.
One such trial which has been suspended is a phase I trial (NCT02303392) investigating selinexor combined with ibrutinib for the treatment of R/R CLL/SLL and aggressive NHLs including MCL and DLBCL. Additionally, results of the SADAL trial (NCT02227251) comparing high and low doses of selinexor in R/R DLBCL patients are highly anticipated.
- Karyopharm Announces Partial Clinical Hold to Pause Enrollment in Selinexor Trials. 2017 Mar 10. https://globenewswire.com/news-release/2017/03/11/934539/0/en/Karyopharm-Announces-Partial-Clinical-Hold-to-Pause-Enrollment-in-Selinexor-Trials.html . [Accessed 2017 Mar 14].